A Multicenter, Retrospective, Observational Study Using Real-world Data to Describe the Safety, Treatment Pattern and Effectiveness of Nirmatrelvir/Ritonavir among Patients treated with Nirmatrelvir/Ritonavir in China

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective observational study

Study drug and medical condition

• Name of medicine:
  PAXLOVID
• Study drug International non-proprietary name (INN) or common name:
  NIRMATRELVIR

  RITONAVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AE30) nirmatrelvir and ritonavir

  nirmatrelvir and ritonavir
• Medical condition to be studied:
  COVID-19

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Study design:
  Retrospective observational study
• Main study objective:
  To describe real-world safety of nirmatrelvir/ritonavir among patients treated with nirmatrelvir/ritonavir in China.
• Outcomes:
  Incidence of AEs and SAEs with explicit attribution to nirmatrelvir/ritonavir, Proportion of patients with nirmatrelvir/ritonavir dose change due to AEs with explicit attribution to nirmatrelvir/ritonavir, Proportion of patients experiencing safety related scenarios; Treatment patterns endpoints include proportion and/or duration of nirmatrelvir/ritonavir, and/or concomitant COVID-19-related treatments, or other concomitant treatments. Effectiveness endpoints include COVID-19 disease severity progressed or death, time to alleviation of signs/symptoms, Proportion of patients with consecutive negative tests and time to first negative test.
• Data analysis plan:
  This study is descriptive in nature and no formal hypothesis testing will be conducted. Continuous variables will be summarized using n, mean, median, minimum, maximum, standard deviation (SD), and 25th and 75th percentiles, and in addition, 95% CI will be provided for effectiveness variables. Categorical variables will be summarized using number and percentages of each category. For continuous and categorical variables, missing data will not be imputed and will be reported as frequency and percentage. Missing data will not be included in the summary statistics. For time-to-event variables (such as time to alleviation of all targeted COVID-19 signs and symptoms), Kaplan Meier (K-M) plots will be generated, and median time will be estimated along with the corresponding 95% CI.

Documents

Study report

C4671043 Paxlovid NI Clinical Study Report_redacted.pdf

C4671043 Paxlovid NI Clinical Study Report Abstract_redacted.pdf